PMID- 12040357
OWN - NLM
STAT- MEDLINE
DCOM- 20020610
LR  - 20190626
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 143
IP  - 5
DP  - 2002 May
TI  - Efficacy and safety of crataegus extract WS 1442 in comparison with placebo in 
      patients with chronic stable New York Heart Association class-III heart failure.
PG  - 910-5
AB  - OBJECTIVE: The purpose of this study was to investigate whether long-term therapy 
      with crataegus extract WS 1442 is efficacious as add-on therapy to preexisting 
      diuretic treatment in patients with heart failure with a more advanced stage of 
      the disease (New York Heart Association [NYHA] class III), whether effects are 
      dose dependent, and whether the treatment is safe and well tolerated. METHODS: 
      Exercise capacity was assessed by use of seated bicycle ergometry with 
      incremental workloads. Scores for subjective symptoms and complaints made by the 
      patients were analyzed. Efficacy and tolerability of the treatments were judged 
      by both the patients and investigators. Safety was assessed by the documentation 
      of adverse events and the safety laboratory. RESULTS: A total of 209 patients 
      were randomized to treatment with 1800 mg of WS 1442, 900 mg of WS 1442, or with 
      placebo. After 16 weeks of therapy with 1800 mg of WS 1442 per day, maximal 
      tolerated workload during bicycle exercise showed a statistically significant 
      increase in comparison with both placebo and 900 mg of WS 1442. Typical heart 
      failure symptoms as rated by the patients were reduced to a greater extent by WS 
      1442 than by placebo. This difference was significant for both doses of WS 1442. 
      Both efficacy and tolerability were rated best for the 1800 mg of WS 1442 group 
      by patients and investigators alike. The incidence of adverse events was lowest 
      in the 1800 mg of WS 1442 group, particularly with respect to dizziness and 
      vertigo. CONCLUSIONS: The data from this study confirm that there is a 
      dose-dependent effect of WS 1442 on the exercise capacity of patients with heart 
      failure and on typical heart failure-related clinical signs and symptoms. The 
      drug was shown to be well tolerated and safe.
FAU - Tauchert, Michael
AU  - Tauchert M
AD  - Klinikum Leverkusen, Leverkusen, Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Flavonoids)
RN  - 0 (Plant Extracts)
RN  - 0 (WS 1442)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Flavonoids/*administration & dosage/adverse effects
MH  - Heart Failure/*drug therapy/physiopathology
MH  - Heart Function Tests
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Phytotherapy
MH  - Plant Extracts/administration & dosage/adverse effects
MH  - Single-Blind Method
EDAT- 2002/06/01 10:00
MHDA- 2002/06/11 10:01
CRDT- 2002/06/01 10:00
PHST- 2002/06/01 10:00 [pubmed]
PHST- 2002/06/11 10:01 [medline]
PHST- 2002/06/01 10:00 [entrez]
AID - S0002870302597672 [pii]
AID - 10.1067/mhj.2002.121463 [doi]
PST - ppublish
SO  - Am Heart J. 2002 May;143(5):910-5. doi: 10.1067/mhj.2002.121463.